Cleared Traditional

K973843 - MSI PRESSURE INFUSOR

K973843 is an FDA 510(k) clearance for MSI PRESSURE INFUSOR, manufactured by Smith Assoc.. The device is a Class 1 General Hospital device with product code KZD cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K973843 · Smith Assoc. · General Hospital
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Oct 1997
Decision
21d
Days
Class 1
Risk

K973843 is an FDA 510(k) clearance for the MSI PRESSURE INFUSOR. Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by Smith Assoc. (Crofton, US). The FDA issued a Cleared decision on October 29, 1997 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5420 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith Assoc. devices

FDA 510(k) Submission Details - K973843

510(k) Number K973843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1997
Decision Date October 29, 1997
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

KZD Device Classification - Class 1, General Controls

Product Code KZD Infusor, Pressure, For I.v. Bags
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KZD Infusor, Pressure, For I.v. Bags

All 10
Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K973843.
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K953290 · Olympus America, Inc. · Oct 1995
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · Abbott Laboratories · Aug 1990
DATA TRAC ANESTHESIOLOGY RECORDER
K851904 · Datascope Corp. · May 1985
NORFOLK/NORWICH PRESSURE INFUSION BOX
K810954 · Medical Innovations Corp. · Apr 1981
MX820-5 PRESSURE INFUSOR 500CC MX820-10
K800560 · Medex, Inc. · Apr 1980
VOLUME CONTROL DEVICE VCD-150
K780465 · Sorensen Research · Jun 1978